NOTICE OF DECISION for INAMED STYLE 410 SILICONE-FILLED BREAST IMPLANTS

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Contact: Device Licensing

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Date issued October 20, 2006

On October 20, 2006, Health Canada issued a Class IV Licence with conditions to Inamed Corporation for Inamed Style 410 Silicone-Filled Breast Implants. Licence issuance was subject to five conditions encompassing annual follow-up data updates to Health Canada and further measures to ensure the safe use of these devices sold in Canada.

A silicone gel-filled breast implant is a sac (implant shell) of silicone "rubber" (elastomer) filled with silicone gel. It is surgically implanted either under (and within) the breast tissue or under the chest muscle.

Breast implants are indicated for reconstruction of the breast following a mastectomy or for breast augmentation. Breast augmentation is indicated for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of an original primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision to correct or improve the result of an original primary breast reconstruction surgery.

Breast implant surgery is contraindicated in women with infection anywhere in their body, women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, and women who are currently pregnant or nursing.

The application included: a quality plan, material specifications, chemical extraction analysis of materials, manufacturing details, process validation information, sterilization data, packaging and shelf life data, mechanical testing, gel-bleed testing and toxicological analysis, biocompatibility studies, prospective clinical data, explant retrieval studies, literature studies, labelling information, and post-marketing plans and projections for large scale long-term clinical trials.

The market authorization was based on the quality of information presented and a demonstration of serious commitment to follow the current prospective clinical trial through to ten years in accordance with the study protocol. Complete clinical study data was provided through three years post-implantation. Most complications were resolved by the three-year follow up, the majority of which were resolved with non-surgical treatment or no treatment at all. As a condition of licensing, Inamed is required to follow-up their Core Study of 1000 patients through to ten years and to commence a large-scale post-approval study designed to measure potential rare adverse events over the long term. An external review of the application by an Expert Advisory Panel (EAP) included input from the patient and scientific communities, as well as other interested members of the public. This consultation resulted in a series of recommendations (EAP Report, November 2005) which were also taken into account during the application review. Inamed Style 410 Silicone-Filled Breast Implants should be used under the conditions stated in the labelling, taking into consideration the potential risks associated with the use of this device.

Detailed conditions for the use of Inamed Style 410 Silicone-Filled Breast Implants are described in the Directions for Use section of the Package Insert. Based on the Health Canada review of data on quality, safety, and effectiveness, it is considered that the benefit/risk profile of Inamed Style 410 Silicone-Filled Breast Implants is acceptable.

Notices of Decision (NDs) are produced in accordance with the Summary Basis of Decision (SBD) initiative. All NDs will be reproduced within the corresponding SBD, normally available within 5 months of product authorization.